BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE

    K Number: K912839 · Decision Sep 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    0
    Applicant Total
    505
    Review Days
    91

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    Basic Information

    Device Name
    LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE
    K Number
    K912839
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baxter Healthcare Corp
    Date Received
    June 26, 1991
    Decision Date
    September 25, 1991
    Product Code
    FBW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FBW Filiform And Filiform Follower

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